On May 5, 2022 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported financial results for the first quarter ended March 31, 2022 and provided a review of recent business and clinical highlights (Press release, Xencor, MAY 5, 2022, View Source [SID1234613648]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our XmAb Fc domains and protein engineering expertise have enabled a broad portfolio of clinical-stage drug candidates, which we and our partners are investigating across many therapeutic areas. Internally we are focused on efficiently using our resources to advance the most promising clinical-stage programs, as well as the next wave of Xencor innovations to enter the clinic – more reduced-potency XmAb cytokines, CD28 T cell engagers and 2+1 CD3 T cell engagers," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Today we are pleased to announce we have dosed the first patient in a potentially registration-enabling study for plamotamab to evaluate the chemotherapy-free, triple combination with tafasitamab and lenalidomide for patients with an aggressive form of non-Hodgkin’s lymphoma."

Dr. Dahiyat continued, "As we progress through the year, we remain on track to present additional clinical data from our vudalimab and plamotamab programs and initial data from our IL2-Fc autoimmune program, XmAb564, in healthy volunteers. In addition, we will present data from our XmAb104 program at the ASCO (Free ASCO Whitepaper) Annual Meeting. In 2022, we also expect to start Phase 1 studies for XmAb819, our ENPP3 x CD3 bispecific antibody for renal cell carcinoma engineered with our multivalent 2+1 format for greater tumor selectivity, and for XmAb808, our B7-H3 x CD28 bispecific antibody. This broad development pipeline is supported by the recent strong revenue from our marketed partnered programs and our robust financial position."

Recent Portfolio Highlights

Plamotamab (CD20 x CD3): Xencor has dosed the first patient in a potentially registration-enabling Phase 2 study, evaluating plamotamab in combination with tafasitamab plus lenalidomide, in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study consists of two parts, a safety run-in intended to establish the safety of the triple combination (Part 1) and a two-arm, open-label cohort where patients will be randomized to receive either the triple combination or tafasitamab plus lenalidomide (Part 2). Xencor is conducting the clinical study in collaboration with MorphoSys AG and Incyte Corporation. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the United States and is marketed by Incyte under the brand name Minjuvi in the European Union. Incyte has exclusive commercialization rights to tafasitamab outside the U.S.

Expansion cohorts in the Phase 1 study of plamotamab are actively recruiting patients with DLBCL and follicular lymphoma (FL) and are dosing using the recommended Phase 2 regimen to further evaluate the safety and efficacy of plamotamab as a monotherapy. Subcutaneous administration of plamotamab will be introduced this year, and the Company plans to present data from the expansion cohorts in the second half of 2022.
Vudalimab (PD-1 x CTLA-4): Xencor is supporting two newly initiated investigator-sponsored studies of vudalimab, in patients with advanced biliary tract cancers and in patients with advanced rare cancers.

The Company is currently enrolling a Phase 2 study in patients with metastatic castration-resistant prostate cancer (mCRPC), in which vudalimab is being evaluated as a monotherapy or in combination with chemotherapy or a PARP inhibitor depending on the tumor’s molecular subtype. The Company plans to present initial data from the study in the second half of 2022 and is currently initiating a Phase 2 study evaluating vudalimab monotherapy in patients with advanced pelvic tumors, including clinically defined high-risk mCRPC and certain gynecologic malignancies.
XmAb306 (IL15/IL15Rα-Fc): Xencor’s co-development partner Genentech, a member of the Roche Group, has initiated a Phase 1 study to evaluate the combination of XmAb306 (RO7310729) and daratumumab, an anti-CD38 monoclonal antibody, in patients with relapsed/refractory multiple myeloma.

XmAb306 is a potency-reduced IL15/IL15Rα-Fc fusion protein targeting NK and T cells for the treatment of patients with cancer. In an ongoing Phase 1 dose-escalation study of XmAb306 in patients with advanced solid tumors, XmAb306 has promoted high levels of sustained NK cell expansion and evidence of peripheral effector T cell proliferation. Additional studies of XmAb306 in combination with other therapeutic agents are also being planned.
XmAb104 (PD-1 x ICOS): An abstract with initial dose-escalation data from the Phase 1 study of XmAb104 in patients with advanced solid tumors was accepted for a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2022.
Preclinical Data Presentations: New data from two preclinical-stage XmAb cytokine programs, an IL18-Fc (XmAb143) and a LAG-3 targeted IL15/IL15Rα-Fc, were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2022.
Tidutamab (SSTR2 x CD3) and XmAb841 (CTLA-4 x LAG-3): The Company will stop internal development of the tidutamab and XmAb841 programs. Neither program demonstrated a competitive clinical profile in recent trials, and the Company has decided to focus resources on new clinical programs. The Company will continue to support patients currently enrolled and being treated.
Progress Across Partnered Programs

Vir Biotechnology, Inc.: In the first quarter of 2022, Xencor recognized $70.3 million in royalty revenue under the Company’s agreement with Vir. Sotrovimab, an antibody that targets the SARS-CoV-2 virus and incorporates Xencor’s Xtend Fc domain for longer duration of action, has been made available by Vir and its partner Glaxo Wellcome UK Limited and GlaxoSmithKline Biologicals S.A. Due to the rapid emergence of the sotrovimab-resistant Omicron BA.2 subvariant in the first quarter, sotrovimab’s authorization was ended in all U.S. regions.
Alexion Pharmaceuticals, Inc.: In April 2022, Ultomiris (ravulizumab-cwvz), which incorporates an Xtend Fc domain, was approved by the U.S. Food and Drug Administration for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. In the first quarter of 2022, Xencor earned $6.1 million from Alexion on net sales of Ultomiris.
Astellas Pharma, Inc.: Astellas has advanced ASP2138, a CLDN18.2 x CD3 XmAb bispecific antibody, into Phase 1 clinical development for the treatment of patients with gastric, gastroesophageal, and pancreatic cancers. Under the Astellas agreement, Xencor applied XmAb bispecific Fc technology to an antigen pair provided by Astellas.
Ultomiris is a registered trademark of Alexion Pharmaceuticals, Inc. Monjuvi and Minjuvi are registered trademark of MorphoSys AG.

Financial Results for the First Quarter Ended March 31, 2022

Cash, cash equivalents, receivables and marketable debt securities totaled $683.6 million as of March 31, 2022, compared to $664.1 million on December 31, 2021. During the first quarter of 2022, the Company received milestone payments and royalties from partners of $83.7 million, which offset spending on operations and resulted in a higher cash balance relative to the 2021 year-end amount.

Revenues for the first quarter ended March 31, 2022 were $85.5 million, compared to $34.0 million for the same period in 2021. Total revenues earned in the first quarter of 2022 included revenues earned from Xencor’s Janssen collaboration, milestone revenue from Astellas, and royalties from the Alexion, MorphoSys and Vir agreements, compared to revenue earned from the Janssen collaboration and royalties and milestones from the Alexion and MorphoSys agreements in the first quarter of 2021.

Research and development expenses for the first quarter ended March 31, 2022 were $47.8 million, compared to $41.4 million for the same period in 2021. Increased research and development spending for first quarter of 2022 compared to 2021 reflects increased spending on the Company’s new development programs including XmAb808 (B7-H3 x CD28) and XmAb662 (IL-12).

General and administrative expenses for the first quarter ended March 31, 2022 were $11.3 million, compared to $8.2 million in the same period in 2021. Increased general and administrative spending for the first quarter of 2022 compared to 2021 reflects increased staffing and additional lease expenses.

Non-cash, stock-based compensation expense for the first quarter ended March 31, 2022 was $10.8 million, compared to $8.3 million for the same period in 2021.

Net income for the first quarter ended March 31, 2022 was $23.6 million, or $0.39 on a fully diluted per share basis, compared to a net loss of $2.5 million, or $(0.04) on a fully diluted per share basis, for the same period in 2021. Net income reported for the first quarter of 2022 compared to net loss for the same period in 2021 is primarily due to increased royalties from partners in 2022.

The total shares outstanding were 59,529,192 as of March 31, 2022, compared to 58,221,953 as of March 31, 2021.

Financial Guidance

Based on current operating plans, Xencor expects to have cash to fund research and development programs and operations through the end of 2025. While future royalty revenues are uncertain, based on recent guidance from GSK, Xencor expects the amount of royalty revenue that it receives from sales of sotrovimab to substantially decline in future reporting periods. The Company expects to end 2022 with between $500 million and $550 million in cash, cash equivalents, receivables and marketable debt securities.

Conference Call and Webcast

Xencor will host a conference call today at 4:30 p.m. ET (1:30 p.m. PT) to discuss the first quarter 2022 financial results and provide a corporate update.

The live call may be accessed by dialing (877) 359-9508 for domestic callers or +1 (224) 357-2393 for international callers and referencing conference ID number 2583486. A live webcast of the conference call will be available online from the Investors section of the Company’s website at www.xencor.com. The webcast will be archived on the company’s website for 30 days.

On May 5, 2022 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives today, reported financial results and business highlights for the first quarter ended March 31, 2022 (Press release, Aileron Therapeutics, MAY 5, 2022, View Source [SID1234613663]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Building on our positive proof-of-concept trial last year in patients with small cell lung cancer treated with topotecan, we view 2022 as a year of validation and execution for Aileron as we seek to bring selective chemoprotection to all patients with p53-mutated cancers regardless of the type of cancer or chemotherapy. Our ongoing NSCLC clinical trial and upcoming breast cancer clinical trial are designed to help us further understand ALRN-6924’s chemoprotective effect against chemotherapy-induced hematologic toxicities as well as other toxicities," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer of Aileron. "We believe that evaluating ALRN-6924 across these two major cancer types treated with different chemotherapies that carry distinct toxicity profiles may provide us with an expanded regulatory opportunity based on established precedent for other supportive care drug approvals."

Nearly 1 million patients are diagnosed with a p53-mutated cancer in the US each year. Aileron is pioneering a precision medicine-based approach known as selective chemoprotection to exclusively treat patients with p53-mutated cancers receiving chemotherapy. ALRN-6924 is designed to selectively protect these patients’ healthy cells from chemotherapy without interfering with chemotherapy’s effects on cancer cells. Aileron’s vision is to bring chemoprotection to all patients with p53-mutated cancers regardless of the type of cancer or chemotherapy.

First Quarter 2022 Highlights and Recent Updates

On track to report interim results from ongoing randomized, double-blind, placebo-controlled Phase 1b clinical trial of ALRN-6924 in advanced p53-mutated NSCLC in June 2022. Aileron plans to enroll 60 patients with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors. Patients are randomized 1:1 to receive carboplatin/pemetrexed plus 0.3 mg/kg ALRN-6924 or placebo for four 21-day treatment cycles.

The company anticipates reporting interim results on the first 20 patients enrolled in June 2022 and topline results on 60 patients in 4Q 2022. The interim readout will include an initial evaluation of the trial’s composite endpoint, composed of the proportion of treatment cycles free of severe toxicities, blood transfusions, and the use of growth factors, as well as dose reductions or dose delays, in patients treated with ALRN-6924 versus placebo.
Completed blinded safety evaluation of NSCLC clinical trial. In 1Q 2022, Aileron conducted a blinded safety evaluation of the first ten patients enrolled in the NSCLC clinical trial who completed the first cycle of treatment with ALRN-6924 and carboplatin plus pemetrexed. The evaluation did not identify any safety concerns, consistent with ALRN-6924’s previously demonstrated safety and tolerability profile.
On track to initiate Phase 1b randomized trial of ALRN-6924 in patients with p53-mutated ER+/HER2- neoadjuvant breast cancer in 2Q 2022. The planned breast cancer trial will evaluate ALRN-6924’s protection against chemotherapy-induced bone marrow toxicities, as well as other toxicities, including alopecia, in patients with p53-mutated ER+/HER2- breast cancer treated with a doxorubicin + cyclophosphamide and docetaxel chemotherapy regimen. The Phase 1b trial is anticipated to enroll up to 30 patients in a parallel group design trial with a dose expansion cohort.
Announced management team updates. In April 2022, Aileron announced the appointment of Christopher Zergebel as Vice President, Program Management and Clinical Operations. Mr. Zergebel previously served as Vice President, R&D Services at Taiho Oncology, Inc., overseeing clinical project management, clinical operations, data management, medical writing, and clinical supplies through all phases of clinical development and through regulatory approvals. Aileron also recently announced the pending departure of Richard Wanstall, Chief Financial Officer. Mr. Wanstall joined Aileron in July 2018 and has been instrumental in Aileron’s successful evolution to a chemoprotection oncology company and helped expand Aileron’s finance, operations, and human resources infrastructure. Prior to joining Aileron, Mr. Wanstall served for four years as Vice President, Finance at Moderna. Aileron has launched a formal search process to identify Mr. Wanstall’s successor.
Upcoming virtual investor event on Thursday, May 19th. Aileron’s management team, joined by guest speakers, will host an investor event to discuss ALRN-6924’s revolutionary potential as the first precision medicine-based supportive care drug, the landscape of chemotherapy-induced toxicities, and the company’s clinical trials and planned 2022 data readouts. To register, visit View Source
First Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents, and investments on March 31, 2022, were $38.1 million, compared to $45.9 million on December 31, 2021. Based on its current operating plan, the company expects its existing cash, cash equivalents, and investments will fund operations into the fourth quarter of 2023.
Research and Development (R&D) Expenses: R&D expenses for the quarter ended March 31, 2022, were $5.9 million, compared to $4.3 million for the quarter ended March 31, 2021. The $1.6 million increase in R&D spending primarily resulted from $0.4 million of increased spending for clinical development of ALRN-6924 related to the Phase 1b clinical trial in patients with advanced p-53 mutated NSCLC and startup activities related to the Phase 1b randomized trial of ALRN-6924 in patients with p53-mutated ER+/HER2- neoadjuvant breast cancer, partially offset by lower spending for the ongoing Phase 1 trial in healthy human volunteers and the completion of the Phase 1b trial in small cell lung cancer in 2021. R&D expenses also increased in the first quarter of 2022 compared to the first quarter of 2021 resulting from increased ALRN-6924 manufacturing activities.
General and Administrative (G&A) Expenses: G&A expenses for the quarter ended March 31, 2022, were $2.5 million compared to $2.7 million for the quarter ended March 31, 2021. The decrease in general and administrative expenses was the result of lower professional services fees during the first quarter of 2022 as compared to the first quarter of 2021.
Net Loss: Net loss for the quarter ended March 31, 2022, was $8.4 million, compared to $7.0 million for the corresponding quarter in 2021. The basic and diluted net loss per share for the first quarter of 2022 was $0.09 compared to $0.08 for the first quarter of 2021.

On May 5, 2022 Avalo Therapeutics, Inc. (Nasdaq: AVTX), reported business updates and first quarter 2022 financial results (Press release, Avalo Therapeutics, MAY 5, 2022, View Source [SID1234613679]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The first quarter has been highly productive for the Avalo Therapeutics team. We executed our pipeline prioritization plan and right-sized the organization needed to deliver what we think will provide the greatest value for our shareholders," said Dr. Garry Neil, Chief Executive Officer of Avalo Therapeutics. "We remain focused on driving our highest value programs forward to meet our timelines. These include our Phase 2 clinical trial of AVTX-002 in NEA and our pivotal trial of ATX-803 in LAD II. We have now initiated both programs, and we expect to dose our first patients in both studies in the second quarter, keeping the programs on track to meet our year-end data release milestones."

Business Update

The Company executed a reduction in workforce in March to align with its previously announced, focused pipeline. With these changes, the Company believes it will achieve substantial cost savings over time while creating a more appropriately sized workforce needed to successfully achieve the Company’s 2022 objectives, most notably obtaining and releasing data for its Phase 2 clinical trial of AVTX-002 in NEA and pivotal trial of AVTX-803 in LAD II. Headcount was reduced by approximately one third from December 31, 2021.
Program Updates and Milestones:

AVTX-002: Anti-LIGHT monoclonal antibody (mAb) targeting immune-inflammatory diseases.
NEA: The Company has initiated its Phase 2 randomized, double-blind, placebo-controlled clinical trial evaluating AVTX-002 in 80 patients with poorly controlled NEA. Top-line data from the trial are expected in the fourth quarter of 2022.
IBD: The Company continues to consider initiating a randomized, double-blind, placebo-controlled clinical study in moderate-to-severe refractory patients in inflammatory bowel disease (IBD).

AVTX-007: Anti-IL-18 mAb targeting adult-onset Still’s disease (AOSD).

AOSD: The Company is evaluating AVTX-007 in a multicenter, Phase 1b study in 12 refractory or steroid-dependent patients with AOSD in two cohorts. Management is currently reviewing preliminary data and the path forward related to this indication. Top-line data are currently expected in 2023, which is subject to change and refinement pending finalization of the review.
AVTX-800 programs (AVTX-801 and AVTX-803): Monosaccharide therapies for two congenital disorders of glycosylation (CDGs): leukocyte adhesion deficiency type II (LAD II, also known as SLC35C1-CDG) and PGM1-CDG.
LAD II: The Company has initiated a single-center (U.S.), double-blind (followed by an open-label extension) pivotal study of AVTX-803 in patients with LAD II. Data from this pivotal trial are expected in the fourth quarter of 2022.
PGM1-CDG: Avalo and the study sponsor remain in dialogue with the U.S. Food and Drug Administration (FDA) to align on a suitable clinical study design for AVTX-801 (PGM1-CDG). Pivotal trial data are expected in 2023. Avalo is currently working with the study sponsor to refine milestone timing.
First Quarter 2022 Financial Update:

As of March 31, 2022, Avalo had $38.5 million in cash and cash equivalents, representing a $16.1 million decrease as compared to December 31, 2021. The decrease was primarily driven by operating expenditures to fund and support pipeline development.

Total operating expenses decreased $9.0 million for the three months ended March 31, 2022 as compared to the three months ended March 31, 2021. The decrease was mainly driven by a $15.6 million decrease in research and development expenses. The decrease in research and development expenses was due to: 1) a $10.0 million upfront license fee incurred in the first quarter of 2021, which did not repeat; and 2) a $5.6 million reduction due to specific timing of manufacturing and clinical trial activities.

The decrease in operating expenses was partially offset by $3.1 million of severance expense and $4.3 million of non-cash stock-based compensation expense recognized in the first quarter of 2022 due to headcount reductions from the pipeline prioritization plan and the termination of employees prior to such plan. Most of these expenses were general and administrative, and they were the primary driver of the increase in general and administrative expenses period over period. The Company expects salary related expenses to decrease beginning in the second quarter as a result of the headcount reductions. The net loss and change in net loss was largely driven by operating expenses.

(a) The condensed consolidated balance sheets as of March 31, 2022 and December 31, 2021 have been derived from the reviewed and audited financial statements, respectively, but do not include all of the information and footnotes required by accounting principles accepted in the United States for complete financial statements.

(a) The unaudited condensed consolidated statements of operations for the three months ended March 31, 2022 and 2021 have been derived from the reviewed financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

On May 5, 2022 Biogen Inc. (Nasdaq: BIIB) and MedRhythms reported that they have entered into a license agreement to develop and commercialize MR-004, an investigational prescription digital therapeutic for the potential treatment of gait deficits in multiple sclerosis (MS) (Press release, Biogen, MAY 5, 2022, View Source [SID1234613695]). The collaboration combines MedRhythms’ digital expertise with Biogen’s leadership and global footprint in MS in order to address significant unmet patient needs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

MedRhythms is developing next-generation prescription digital therapeutics across a broad range of indications in neurology via a technology platform that leverages advancements in neuroscience and music to target improved walking and mobility. MR-004 is MedRhythms’ pipeline candidate in MS, which aims to improve gait and gait-related aspects of movement, potentially providing MS patients with improved independence related to mobility. If approved, MR-004 has the potential to become the first prescription digital therapeutic for gait deficit in MS. MedRhythms is currently conducting two ongoing feasibility studies for MR-004, and, based on the readout of the first study, plans to initiate a registrational trial in the near future.

"As part of our aspiration in digital health, together with MedRhythms we aim to advance a new, innovative treatment option for people living with MS that may help address walking impairment, a common issue that impacts their overall quality of life," said Martin Dubuc, Head of Biogen Digital Health. "Pioneering in digital therapeutics exemplifies Biogen’s commitment to advance novel therapies that we hope will improve outcomes for people living with MS."

"At MedRhythms, we are committed to redefining what is possible for people living with neurologic diseases by building evidence-based products that meaningfully impact symptoms that have been underserved by traditional treatment modalities," said Brian Harris, Chief Executive Officer of MedRhythms. "We look forward to what our collaboration with Biogen, a global leader in MS, could mean for the patients we serve around the world."

Under the terms of the agreement, Biogen will make an upfront payment of $3 million to MedRhythms. Should certain development and commercial milestones be achieved, MedRhythms will be eligible to receive up to $117.5 million in potential milestone payments. MedRhythms is also eligible to receive tiered royalties in the high-single digits to low-teens on potential global sales.

On May 15, 2022 Elpiscience Biopharmaceuticals, Inc. ("Elpiscience"), a clinical-stage biopharmaceutical company focused on developing next-generation immunotherapies to benefit cancer patients worldwide, reported partner Compass Therapeutics reported positive interim ES104 (also known as CTX-009) Phase 2 data in combination with paclitaxel in patients with biliary tract cancers (BTC) (Press release, Elpiscience, MAY 5, 2022, View Source [SID1234613705]). ES104 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In the study, ES104 demonstrated:

42% overall response rate (ORR) based on 10 patients with Partial Responses (PRs), including 9 PRs confirmed by RECIST 1.1 and 1 PR pending confirmation
Anti-tumor activity in previously treated patients with a clinical benefit rate (CBR) of 92% based on 22 patients with a PR or stable disease (SD) out of 24 enrolled patients
Well-tolerated and preliminary safety profile consistent with prior studies
The Phase 2 study in patients with BTC is currently being conducted at four leading medical centers in Korea and Compass Therapeutics plans to open additional sites in the United States. In China, Elpiscience is currently enrolling patients in a ES104 Phase 1/2 study for the treatment of unresectable locally advanced or metastatic colorectal cancer (CRC). ES104 is currently the only clinical-stage bispecific antibody targeting VEGF and DLL4 in China.

"We are encouraged by the impressive interim Phase 2 data in BTC patients from our partner," said Steve Chin, Chief Medical Officer of Elpiscience. "ES104 in combination with paclitaxel showed a high ORR including responses in all four BTC subtypes and good overall tolerability consistent with prior studies. We believe in the clinical strategy to simultaneously target VEGF and DLL4 and look forward to our study findings in advanced CRC patients."

For more information on the Phase 1/2 clinical study in patients with unresectable locally advanced or metastatic CRC, refer to Clinicaltrials.gov identifier NCT05167448.

About ES104

ES104 is a bispecific antibody that simultaneously blocks Delta-like ligand 4/Notch (DLL4) and vascular endothelial growth factor A (VEGF-A) signaling pathways, which are critical to angiogenesis and tumor vascularization. Pre-clinical and early clinical data of ES104 show that blocking both pathways provides robust anti-tumor activity across several solid tumors, including colorectal, gastric, cholangiocarcinoma, pancreatic, and non-small cell lung cancer. Partial responses to ES104 as monotherapy have been observed in heavily pre-treated cancer patients, who were resistant to currently approved anti-VEGF therapies. ES104 has completed a Phase 1 monotherapy dose-escalation and expansion study (NCT03292783). Phase 1b and Phase 2 clinical studies (NCT04492033) in combination with chemotherapy are ongoing. Elpiscience licensed ES104 greater China rights from Compass Therapeutics in January 2021 and is conducting Phase 1/2 study in China for treatment in patients with unresectable locally advanced or metastatic colorectal cancer.